Fourth-Generation HIV Rapid Tests: Enhanced Sensitivity and Reduced Diagnostic Window for HIV-1 Primary Infection Screening

IF 6.8 3区 医学 Q1 VIROLOGY
Vincent Guiraud, Angèle Naizet, Habiba Khan, Ghizlane Benhafoun, Pierre Hernandez, Luigi Piccin, Agnès Pichon, Ay Ling Leng, Léna Yousfi, Agnès Gautheret-Dejean
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Abstract

As most HIV rapid tests (HRT) detect only HIV-1/2 antibodies, their performance during primary HIV infection is poor. Determine HIV Early detect (Abbott) (Determine) is the only HRT with an HIV-1 p24-antigen detection, but the impact of this addition in shortening the diagnostic window remains unclear. A total of 183 HIV-1 primary infection samples were tested using the HRTs Determine and ONE STEP anti-HIV (1&2) Test (InTec Products) (One-Step). The pre-seroconversion subgroup was defined as p24-antigen positivity without Western blot nor Liaison XL (fouth generation enzyme immunoassay with distinct signal for p24-antigen and HIV-1 antibody) HIV-1 antibodies. Global sensitivity (95% CI) was 95% (91–97) for Determine versus 80% (74%–85%) for One-Step (difference p = 1.38e−06). Pre-seroconversion subgroup sensitivity was lower, at 71.9 (54.6%-84.4%) for Determine and 9.7% (3.3%–24.9%) for One-Step. Among the 45 samples with an HIV-1 infection date, no HRT was reactive up to 2 weeks. Between 2 and 3 weeks, Determine sensitivity was 78% (45%–95%) versus 56% (27%–81%) for One-Step. From 3 weeks to 1 month Determine sensitivity was 90% (62%–98%) and One-Step 45% (21%–72%). The last negative sample occurred at 3 weeks for Determine versus 70–90 days for One-Step. HRT with p24-antigen detection significantly shortens the diagnostic window from approximatively 3 months to 1 month. HRTs should be used with caution in the first month after HIV infection.

Abstract Image

第四代 HIV 快速检测试剂盒:第四代 HIV 快速检测试剂盒:提高 HIV-1 初诊感染筛查的灵敏度并缩短诊断窗口期。
由于大多数艾滋病毒快速检测试剂盒(HRT)只能检测 HIV-1/2 抗体,因此在艾滋病毒原发感染期间的性能较差。Determine HIV 早期检测试剂盒(雅培)(Determine)是唯一能检测 HIV-1 p24 抗原的快速检测试剂盒,但其对缩短诊断窗口期的影响仍不明确。使用 Determine 和 ONE STEP 抗 HIV (1&2) 检测试剂盒(InTec 产品公司)(One-Step)共检测了 183 份 HIV-1 初诊感染样本。血清转换前亚组的定义是 p24 抗原阳性,但无 Western 印迹或 Liaison XL(第四代酶联免疫测定,p24 抗原和 HIV-1 抗体信号明显)HIV-1 抗体。Determine 的总体灵敏度(95% CI)为 95% (91-97),而 One-Step 为 80% (74%-85%)(差异 p = 1.38e-06)。血清转换前亚组敏感性较低,Determine 为 71.9%(54.6%-84.4%),One-Step 为 9.7%(3.3%-24.9%)。在 45 份有 HIV-1 感染日期的样本中,2 周内没有 HRT 反应。2 到 3 周内,Determine 的灵敏度为 78%(45%-95%),而 One-Step 为 56%(27%-81%)。从 3 周到 1 个月,Determine 的灵敏度为 90%(62%-98%),One-Step 为 45%(21%-72%)。Determine 的最后阴性样本出现在 3 周,而 One-Step 的最后阴性样本出现在 70-90 天。带有 p24 抗原检测功能的 HRT 大大缩短了诊断窗口期,从大约 3 个月缩短到 1 个月。在感染艾滋病毒后的第一个月应慎用 HRT。
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来源期刊
Journal of Medical Virology
Journal of Medical Virology 医学-病毒学
CiteScore
23.20
自引率
2.40%
发文量
777
审稿时长
1 months
期刊介绍: The Journal of Medical Virology focuses on publishing original scientific papers on both basic and applied research related to viruses that affect humans. The journal publishes reports covering a wide range of topics, including the characterization, diagnosis, epidemiology, immunology, and pathogenesis of human virus infections. It also includes studies on virus morphology, genetics, replication, and interactions with host cells. The intended readership of the journal includes virologists, microbiologists, immunologists, infectious disease specialists, diagnostic laboratory technologists, epidemiologists, hematologists, and cell biologists. The Journal of Medical Virology is indexed and abstracted in various databases, including Abstracts in Anthropology (Sage), CABI, AgBiotech News & Information, National Agricultural Library, Biological Abstracts, Embase, Global Health, Web of Science, Veterinary Bulletin, and others.
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